DE602004011934T2 - APPLICATOR WITH TWO ENDS TO DELIVER TWO LIQUIDS, ESPECIALLY ADHESIVE COMPONENTS - Google Patents

Abstract

An applicator for dispensing two separate tissue adhesives includes a generally elongate body having two distinct interior regions, each containing one of the two tissue adhesives. Hinged levers associated with each region selectively force the expulsion of the adhesive from the end portions of the applicator in response to application of force by the operator.

Description

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

The The invention relates to improved applicators for the application of adhesives and special medical adhesives. It causes an accurate Application of small amounts of adhesive at specific locations, to create solid point bonds analogous to spot welds. Also allowed the application of a sealant layer over the Area, which has been connected, creating an elastic seal of the Liability brought surfaces is allowed.

she is special when closing long wounds in mammalian tissue useful, as in surgical incisions or tears.

STATE OF THE ART

Surgical incisions or tears are currently occluded using sutures, staples, tape or liquid tissue adhesives. Sutures, staples, and adhesives have been widely used for many years, and tissue adhesives have recently gained significant acceptance with the market introduction of DERMABOND ^(TM) from J & J in the US and Liquiband and other products in Europe. Tissue adhesives are typically applied as a thin line or wide strip along the course of the wound after the skin edges are brought together (approximated). The edges of the wound must then be held together as the adhesive sets. One of the advantages of the tissue adhesives over the older forms of wound closure is that they both seal and seal the wound to allow fluid retention and to keep away infectious agents. This may allow the patient to bathe almost immediately without fear of blood loss or infection.

One Tissue adhesive is typically a low viscosity fluid which is a high affinity to tissue and it wets very easily. The applicators are typically tubes or ampoules with wide ends that are squeezed out by the user have to, around the glue for to eject an application. The release of the liquid with low viscosity becomes common not well controlled and can cause a flow of the glue into unwanted areas to lead, where it causes unwanted adhesions can. There are many cases about that it was reported where glue ran into the eyes of a patient is, or where the doctor's glove or the instruments on the patient because of poor control of glue application. additionally solid tissue adhesives tend to be inelastic, whereas elastic tissue adhesives tend to be weaker compounds to effect. Therefore, the tissue adhesives tended to close wounds to be a compromise between elasticity and bond strength.

Typical of the prior art is DERMABOND ^(TM) manufactured by Closure Corporation and sold by the Ethicon Division of J & J. This product is 2-octyl cyanoacrylate, which is presented in a plastic applicator containing a frangible glass ampule. The end of the applicator contains a porous spherical head approximately 5/16 "in diameter, through which the adhesive is applied after the inner glass ampoule is broken. The adhesive exhibits a low viscosity, typically less than 10 cps, and quickly wets mammalian skin, allowing it to pass unhindered across the skin. The application of tissue adhesive from this head is difficult to control. The instructions of the DERMABOND ^(TM) instruct the user to "approach the wound edges with gloved fingers or sterile forceps. The liquid DERMABOND ^(TM) adhesive is applied slowly to the surface of the approximated wound edges in several (at least three) thin layers using a gentle brushing motion. You have to wait approximately 30 seconds between applications or layers. Manual approach of the wound edges approximately 60 seconds after the last layer is to be maintained. "The adhesive layer formed by this process is typically 1/4 in. Or more wide and quite thick due to the application of three layers despite the fact that 2-octyl cyanoacrylate has a lower modulus than the lower homologues, such as ethyl, butyl and hexyl cyanoacrylate, the procedure is not suitable for sealing incisions or cracks longer than a few centimeters because the Wound margins must be fully approximated before applying the adhesive layers.

More recently, some physicians have adopted a technique of "spot-welding" a wound with tissue adhesives by applying very small spots of adhesive at intervals along a wound so as to approximate only the wound edges where they make the connection, and they can seal much longer wounds, and once the wound is properly closed, the doctor can seal the wound by running a thin line of tissue adhesive along the length of the wound leaves. This advancement in the method of sealing wounds is possible because of the solid, fast-curing adhesives that can be applied in very small quantities. However, the solid, fast-curing adhesives tend to be stiff, and the seal centerline formed from this adhesive can make the wound uncomfortable.

The US Patent No. 5976102 discloses an applicator according to the preamble of patent claim 1.

BRIEF SUMMARY OF THE INVENTION

In accordance with the invention, an applicator is provided having first and second end portions from which first and second single fluids (eg, liquids) can be dispensed. The applicator comprises: a housing assembly defining first and second separate regions adapted to receive the first and second individual fluids, the first and second regions being in fluid communication with the exterior of the applicator at each of the first and second end portions of the applicator Applicator are and are separated from each other so that the first and second liquid does not mix with each other within the housing assembly. The applicator also includes
a first pressure device that is a first articulated lever having a first piston portion for providing sufficient pressure to the first fluid to cause the same to exit the applicator in the first end portion; and
a second pressure device which is a second articulated lever having a second piston portion for providing a sufficient pressure to the second fluid to cause the exit of the same from the applicator in the second end portion.

BRIEF DESCRIPTION OF THE VARIOUS VIEWS THE DRAWINGS

Lots Advantages of the present invention will become apparent to those skilled in the art this patent specification in conjunction with the accompanying drawings in which the same reference numerals are given in the same Elements are used.

It demonstrate:

1A a left view of the applicator in accordance with the invention;

1B a plan view of the applicator 1A ;

2 a sectional view of the applicator 1B along the line AA;

2A an expanded view of a section 2 ;

3 a sectional view of the applicator 1A along the line BB;

4 a view showing the use of the applicator of the invention to apply a solid fast-curing adhesive on an incision; and

5 a view showing the use of the applicator of the invention to a more elastic tissue adhesive to the incision in 4 applied.

DETAILED DESCRIPTION OF THE INVENTION

1A and 1B are each a left side view and a top view of an applicator 100 in accordance with the invention. The applicator 100 generally has a housing assembly 102 and a first and second end portion, respectively 104 and 106 on. The applicator 100 is designed to separate two quantities of liquid (not shown) contained therein and to selectively remove the liquids at the end portions 104 and 106 emits.

2 and 3 are sectional views of the applicator 100 each along the lines AA and BB in 1B and 1A , The housing assembly 102 includes a generally elongated body 202 which at one end by means of a ring structure 204 and at the other end by means of an end cap 206 is covered. The housing assembly 102 defines a chamber in which a pair of deformable tubes 208a and 208b is arranged, each of which is at least partially in an inner area ( 210a . 210b ) of which a hermetically sealed ampoule ( 212a . 212b ) with a suitable adhesive. Preferably, the ampoule contains 212a a solid, fast-curing adhesive, such as n-butyl cyanoacrylate or pentyl cyanoacrylate, while the ampoule 212b contains a more elastic tissue adhesive, such as octyl cyanoacrylate or hexyl cyanoacrylate. Other types of adhesives may also be used, as detailed below. It will also be understood that in some applications the two ampoules 212a and 212b would contain the same adhesive compound.

The areas 210a and 210b are separated from each other so that mixing together the contents of the ampoules 212a and 212b will not be done if the ampoules in the following de waisted described manner, such as by breaking. The separation is mainly by means of a middle connector 214 which serves to cause the ends of the tubes 208a and 208b as a generally tubular structure with a central impermeable partition wall formed therein 216 is trained. Holding the opposite end of the tube 208b takes place through a ring structure 204 acting as a conduit for fluid communication between the area 210b and the outside of the applicator 100 serves.

Likewise, the tube becomes 208a at its opposite end by an end cap 206 worn, with the tube 208a between the outside of the end cap 206 and the inside of the body 202 fits, as detailed in 2A will be shown. To the end cap 206 pushes a nozzle 218 on, with a middle channel in alignment with one in the end cap 206 trained middle channel is provided. These middle channels form a fluid line 220 that creates a fluid connection between the area 210a and the outside of the applicator 100 allowed. filter 222a and 222b are in the fluid flow paths between the inner regions 210a and 210b and the outside of the applicator 100 arranged without obstructing the passage of the adhesives contained in the ampoules. A spherical microporous head 222a is also in the area of the end of the line 220 present to aid in distributing the fluid.

Pressure devices, such as the toggle lever 224a . 224b and 224b ' are present to selectively and controllably apply a force to the tube by the operator's hand (not shown) 208a and 208b exercise, causing the ampoules 212a and 212b by being broken, and finally by the discharge of their contents from the applicator 100 is enforced.

The articulated levers 224a . 224b and 224b ' have respective lever sections ( 224a _I . 224b _I and 224b _I ' ), which come into contact with the operator's fingers to receive an inward pressure therefrom, that is, a pressure in the direction of the applicator 100 , The articulated levers 224a . 224b and 224b ' also have respective piston sections ( 224a _p . 224b _p and 224b _p ' ), with the tubes 208a and 208b engage directly, as shown, or indirectly by means of some other known power transmission mechanism, and transmit the force from the operator's fingers to the tubes, thereby deforming the tubes and the ampoules containing the fluid 212a and 212b to be broken in it. To facilitate the joint function, the toggle lever 224a . 224b and 224b ' rotatable on the housing assembly 102 attached, preferably on the elongated body 202 , in each case in the places 224a _i . 224b _i and 224b _i ' , The attachment is preferably by means of an elastic connecting bridge of integrated material with the lever and / or the elongate body 202 , Alternatively, a conventional hinge assembly (not shown) may be provided for that purpose. The piston sections 224a _p . 224b _p and 224b _p ' the lever 224a . 224b and 224b ' are shaped so that their contours and volume at the point of interaction with the tubes 208a and 208b To allow a good control of the volume of the liquid coming from the areas 210a and 210b during the inward movement of the lever is pressed out.

The materials of the components of the applicator 100 are chosen so that they are compatible with each other and with the adhesives contained in the ampoules 212a and 212b are included, especially for those components that should come into contact with the adhesives. Biological compatibility is also important to reduce the risk of patient injury and / or toxicity. If the adhesives are cyanoacrylates, materials that do not react with the cyanoacrylates would be selected. Polymeric materials can be used for the components of the applicator 100 as long as the polymeric materials are compatible with the adhesives (ie, the components of the applicator will not readily degrade in the adhesives, the adhesives will not degrade the components of the applicator, and the components of the applicator become the polymerization of any prepolymer do not effect). In this regard, it is preferred to use high density polyethylene or polypropylene in the components of the applicator because of their inertness in the presence of the adhesive compositions described herein. Other materials that are compatible with the adhesive compositions can be readily determined by one skilled in the art and include, for example: other polyolefins such as polyethylene ( 80A - 80D ), Polyester-polyether block copolymer ( 30D - 80D ), Alcryn (chlorinated polyolefin) ( 60A - 80A ), Pebax (polyamide-polyether block copolymer) ( 25D - 70D ); Fluoropolymers such as PTFE (polytetrafluoroethylene such as Teflon ^(TM) , perfluoroalkoxy resin, fluorinated ethylene-propylene polymers, ETFE and SEES (styrene-ethylene-butadiene-styrene); silicones; silicone interpenetrating nylons; 6, 6/10 and 6/12) and polyamide.

How out 4 can be seen, and with reference to 2 , becomes an incision during use 400 following a surgical procedure, close the head 105 of the applicator 100 in the immediate vicinity of the incision brought, and the toggle lever 224a ( 2 ) is depressed by the operator (not shown) with sufficient force around the ampule 212a to break and cause a small amount of solid fast-curing adhesive 402 Included in the area 210a through the filter 222a and the channel 220 to the outside of the applicator 100 flows. The solid fast-curing adhesive becomes points 404 applied to the edges of the incision in a manner analogous to spot welding to effect a strong bond to hold the edges together at least long enough to apply the more elastic tissue adhesive contained in the ampoule 212b is included.

The application of the more elastic tissue adhesive from the ampoule 212b is in 5 illustrated and performed by the end section 106 of the applicator 100 in the immediate vicinity of the incision 400 is brought, either before or after the ampoule 212b through the action of the toggle lever 224b and 224b ' was broken. There will be sufficient force on the toggle 224b and 224b ' applied to the elastic tissue adhesive from the area 210b through the filter 222b and from the applicator 100 to launch out. The filter 222b runs along the incision 400 while maintaining sufficient pressure on the toggle levers 224b and 224b ' is applied to cover the area of the incision and to effect its complete closure.

Cyanoacrylate adhesive compositions

The Adhesive liquids which are applied by means of the applicator of the present invention can, can a wide variety of cyanoacrylate adhesive compositions exhibit. However, it should be understood that the present Invention is not limited to a specific type of adhesive, and a suitable medical (or non-medical) adhesive can be used. In general, the first ampoule or container a stronger bonding and less elastic cyanoacrylate adhesive composition contain, such as n-butyl cyanoacrylate, and the second container will contain a more elastic tissue adhesive, such as Octyl or hexyl cyanoacrylate.

In accordance with an optional preferred aspect of the present invention Both are containers Containing cyanoacrylate adhesive compositions. Preferably For example, the cyanoacrylate compositions used have cyanoacrylate prepolymer compositions applied to the skin surface as a liquid / gel can be. Optionally, you can the cyanoacrylate prepolymers include therapeutic agents such as For example, analgesics, anti-inflammatories, antimicrobials and the same.

worin
R aus der Gruppe ausgewählt wird, die besteht aus:
Alkyl mit 1 bis 10 Kohlenstoffatomen,
Alkenyl mit 2 bis 10 Kohlentoffatomen,
Cycloalcylgruppen mit 5 bis 8 Kohlenstoffatomen,
Phenyl,
2-Ethoxyethyl,
3-Methoxybutyl,
und einem Substituenten der Formel:

worin
jedes R' unabhängig aus der Gruppe ausgewählt wird, die besteht aus:
Wasserstoff und Methyl, und
R'' aus der Gruppe ausgewählt wird, die besteht aus:
Alkyl mit 1 bis 6 Kohlenstoffatomen,
Alkenyl mit 2 bis 6 Kohlenstoffatomen,
Alkynyl mit 2 bis 6 Kohlenstoffatomen,
Cycloalkyl mit 3 bis 8 Kohlenstoffatomen,
Aralkyl, ausgewählt aus der Gruppe, die aus Bencyl, Methylbencyl und Phenylethyl besteht,
Phenyl und Phenyl, substituiert mit 1 bis 3 Substituenten, ausgewählt aus der Gruppe, die aus Hydroxyl, Chloro, Promo, Nitro, Alkyl mit 1 bis 4 Kohlenstoffatomen und Alkoxy mit 1 bis 4 Kohlenstoffatomen besteht.Preferably, the polymerizable cyanoacrylate prepolymers have cyanoacrylate esters which are represented in monomeric form by the formula I:

wherein
R is selected from the group consisting of:
Alkyl of 1 to 10 carbon atoms,
Alkenyl having from 2 to 10 carbon atoms,
Cycloalcyl groups of 5 to 8 carbon atoms,
phenyl,
2-ethoxyethyl,
3-methoxybutyl,
and a substituent of the formula:

wherein
each R 'is independently selected from the group consisting of:
Hydrogen and methyl, and
R '' is selected from the group consisting of:
Alkyl of 1 to 6 carbon atoms,
Alkenyl of 2 to 6 carbon atoms,
Alkynyl of 2 to 6 carbon atoms,
Cycloalkyl of 3 to 8 carbon atoms,
Aralkyl selected from the group consisting of benzyl, methylbencyl and phenylethyl,
Phenyl and phenyl substituted with 1 to 3 substituents selected from the group consisting of hydroxyl, chloro, promo, nitro, alkyl of 1 to 4 carbon atoms and alkoxy of 1 to 4 carbon atoms.

More preferably, in the cyanoacrylate esters of the formula IR is an alkyl group having 2 to 10 carbon atoms, which is ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, n-pentyl, isopentyl, n-butyl Hexyl, isohexyl, 2-ethylhexyl, n-heptyl, octyl, nonyl and decyl. Mixtures of such compounds can also be used as described by Berger and coworkers in U.S. Patent No. 5,998,472 is disclosed. For the stronger, less elastic adhesive, R is preferably ethyl, butyl or pentyl, thereby imparting a higher modulus to the resulting polymer film. For the more elastic adhesive R is preferably hexyl or octyl. In a highly preferred embodiment, the first container contains an n-butyl cyanoacrylate ester, and the second Be container contains an octyl cyanoacrylate ester.

It It should be understood that the term "polymerizable cyanoacrylate ester" is polymerizable Compositions which are cyanoacrylate monomers or polymerizable Having oligomers which in their monomeric form are preferably compounds which are embodied by I as above.

The Polymerize polymerizable cyanoacrylate ester described herein herein quickly in the presence of water vapor or tissue protein, and the n-butyl cyanoacrylate combines with the mammalian skin tissue without a histotoxicity or cytotoxicity is caused.

Polymerizable cyanoacrylate esters are known in the art and are described, for example, in US Pat US Patent No. 3527224 . 3591676 . 3667472 . 3995641 . 4035334 and 4650826 described.

Optionally, the cyanoacrylate compositions that are applied by the present applicator may include a "biocompatible plasticizer." As used herein, the term "biocompatible plasticizer" refers to any material that is soluble or dispersible in the cyanoacrylate composition that exhibits the elasticity of the polymer resulting polymer film coating on the skin surface, and which is compatible in the amounts used with the skin, measured by the absence of moderate to severe skin irritation. Suitable plasticizers are well known in the art and include those described in U.S. Pat U.S. Patent No. 2784127 and 4444933 be revealed. Specific plasticizers include, by way of example only, acetyl tri-n-butyl citrate (preferably ~20% or less by weight), acetyl trihexyl citrate (preferably ~20% or less by weight), butyl benzyl phthalate, dibutyl phthalate, dioctyl phthalate, n-butyryl trichloride. n-hexyl citrate, diethylene glycol dibenzoate (preferably ~20% by weight or less) and the like. The particular biocompatible plasticizer employed is not critical, and preferred plasticizers include dioctyl phthalate and C ₂ -C ₄ acyl tri-n-hexyl citrates.

Optional The cyanoacrylate composition used by the present applicator as well as an "antimicrobial agent." Like as used herein, the term "antimicrobial agent" refers to agents that are microbes (ie, bacteria, fungi, yeasts and viruses) destroy their development and their pathogenic effects are prevented.

Preferred cyanoacrylate compositions useful in the practice of this invention are also disclosed by Greff et al US Patent No. 5480945 disclosed. In a particularly preferred embodiment, the cyanoacrylate adhesive composition further comprises an antimicrobially effective amount of a compatible antimicrobial agent. Such compositions preferably comprise from about 0.1 to about 30 and preferably from about 0.5 to about 10 weight percent of the compatible antimicrobial agent either as a solution or as a suspension based on the total weight of the composition. Compatible antimicrobial agents are those that are either soluble or salable in the cyanoacrylate composition, that do not cause premature polymerization of the cyanoacrylate composition, that do not inhibit polymerization of the cyanoacrylate composition when applied to the mammalian skin, and that are compatible with its intended use. including the biological compatibility with the skin of the patient. Suitable such compositions are in US Patent No. 6475502 , which discloses compositions of cyanoacrylate / povidone-iodine complexes, and in US patent application Ser. 60/498913, filed August 29, 2003, which discloses compositions of cyanoacrylate esters and phenol.

The Use of a compatible antimicrobial agent in the compositions allows the agent to be released from the polymer film, thereby reducing the microbial growth area adjacent to the film becomes.

Other medicaments suitable for use in conjunction with the cyanoacrylate compositions include corticosteroid steroids such as those described by Grell and co-workers in U.S. Pat US Patent No. 5962010 and analgesic compounds such as lidocaine. The former reduces inflammation, whereas the latter reduces pain. Combinations of a steroid with an analgesic are also included.

The The above are examples of Methods of implementation of the invention, and they are not intended as a limitation. For those professionals It will be apparent that modifications are made thereto can, without departing from the scope of the invention, as in the following claims is set out.

Claims (15)

An applicator having first and second end portions from which first and second individual fluids may be dispensed, the applicator comprising: a housing assembly defining first and second separate regions adapted are to receive the first and second individual fluids, wherein the first and second regions are in fluid communication with the exterior of the applicator at each of the first and second end portions of the applicator and are separated from each other such that the first and second fluids are not within the housing assembly mix with each other; a first pressure device that is a first articulated lever having a first piston portion for providing a sufficient pressure to the first fluid to cause the exit of the same from the applicator in the first end portion; characterized by a second pressure device that is a second articulated lever having a second piston portion for providing sufficient pressure to the second fluid to cause the exit of the same from the applicator in the second end portion. An applicator according to claim 1, further comprising a first hermetically sealed ampule, which in the first area is arranged and the first liquid contains where the first lever works to the integrity of the first Destroying ampoule, so the first liquid emerges from it. An applicator according to claim 2, further comprising a first filter for preventing the flow of debris from the first ampule having the applicator out. An applicator according to claim 1 or 2, further comprising a second hermetically sealed ampule, in the second Area is arranged and contains the second liquid, wherein the second lever works to destroy the integrity of the second ampoule, so that the second fluid emerges from it. An applicator according to claim 4, further comprising a second filter for preventing the flow of fragments of the second ampoule having the applicator out. An applicator according to claim 1, wherein the first liquid a fast-curing one solid prepolymer adhesive and the second liquid is a prepolymer adhesive is that can form an elastic sealant layer. An applicator according to claim 1, wherein the first liquid having n-butyl cyanoacrylate. An applicator according to claim 1, wherein the second liquid Having octyl cyanoacrylate. An applicator according to claim 1, wherein the second liquid a mixture of butyl and octyl cyanoacrylate. An applicator according to claim 1, wherein the second liquid a mixture of butyl and decyl cyanoacrylate. An applicator according to claim 7, wherein the second liquid Having octyl cyanoacrylate. The applicator of claim 1, wherein the first end portion adapted to the first liquid at specific locations, and at the second end portion adapted to the second liquid as a sealant layer. An applicator according to claim 1, wherein the first and second liquid Cyanoacrylate prepolymers. An applicator according to claim 1, wherein the first and the second end portion at the opposite ends of the applicator are. The applicator of claim 1, wherein the first end portion a spherical one microporous head and the second end portion has an output filter.